Regulatory Writing Senior Manager

Amgen; Thousand Oaks (CA); Hybrid; USD 140,000 - 189,000; Full time

Benefits offered by this job

Flexible work options including remote

Comprehensive benefits package

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off plans

Job summary

Amgen is seeking a Regulatory Writing Senior Manager to lead the authoring and oversight of regulatory submission documents for complex product programs in Thousand Oaks, CA. This role drives cross-functional collaboration and ensures adherence to SOPs while mentoring contract writers and guiding timelines.

The position requires advanced degrees and extensive medical writing experience within biotech/pharma, with flexible work arrangements and a comprehensive benefits package.

Qualifications

• Doctorate degree and 2 years of directly related experience
• Master’s degree and 6 years of directly related experience
• Bachelor’s degree and 8 years of directly related experience
• Associate’s degree and 10 years of directly related experience
• High school diploma / GED and 12 years of directly related experience

Responsibilities

• Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
• Conduct the formal review and approval of authored documents, following applicable standard operating procedures
• With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
• Provide functional area input for Global Regulatory Plan and team goals
• Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
• Lead departmental and cross-departmental initiatives, as appropriate
• Generate document timelines

Skills

Regulatory writing

Leadership

Cross-functional collaboration

Document management

People management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Regulatory Writing Senior Manager Live

What you will do

Let’s do this. Let’s change the world.

• Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans


• Conduct the formal review and approval of authored documents, following applicable standard operating procedures


• With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications


• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)


• Provide functional area input for Global Regulatory Plan and team goals


• Supervise the work of contract and freelance writers and mentor junior medical writers as assigned


• Lead departmental and cross-departmental initiatives, as appropriate


• Generate document timelines

Win What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications

• Doctorate degree and 2 years of directly related experience


• Master’s degree and 6 years of directly related experience


• Bachelor’s degree and 8 years of directly related experience


• Associate’s degree and 10 years of directly related experience


• High school diploma / GED and 12 years of directly related experience

Preferred Qualifications

• Experience with regulatory documents in Regulatory Affairs, Research, Development or related area


• 5+years of experience in medical writing in the Biotech/Pharmaceutical industry

Thrive What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well‑being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.


• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan


• Stock-based long-term incentives


• Award-winning time-off plans and bi-annual company-wide shutdowns


• Flexible work models, including remote work arrangements, where possible

Salary Range 139,581.90USD -188,846.10 USD

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Equal Opportunity Employer

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen